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A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01303796
First received: February 21, 2011
Last updated: April 13, 2015
Last verified: September 2012
  Purpose

This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine, or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Sapacitabine and decitabine
Drug: Decitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete remission with duration [ Time Frame: Up to 43 months ] [ Designated as safety issue: Yes ]
  • Complete remission with incomplete platelet count recovery and duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Partial remission with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Hematological improvement with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Stable disease with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Number of units of blood product transfused [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]
  • Hospitalized days [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • 1-year survival [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 485
Study Start Date: January 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Sapacitabine and decitabine
Drug: Sapacitabine and decitabine
Sapacitabine administered in alternating cycles with decitabine
Active Comparator: Arm C
Decitabine
Drug: Decitabine
Decitabine alone

Detailed Description:

This is a multicenter, randomized, Phase 3 study comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed AML based on WHO classification
  • Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
  • ECOG performance status 0-2
  • Adequate renal function
  • Adequate liver function
  • Able to swallow capsules
  • Agree to practice effective contraception
  • Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

  • AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
  • Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding MDS or MPD
  • Known or suspected central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness
  • Known hypersensitivity to decitabine
  • Known to be HIV-positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303796

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
Scripps Cancer Center
La Jolla, California, United States, 92037
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06850
United States, Florida
Shands Cancer Hospital at University of Florida
Gainesville, Florida, United States, 32608
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, United States, 46237
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
St. Louis University Cancer Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
John Theurer Cancer Center at the Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Westchester Hematology Oncology Group, PC
Hawthorne, New York, United States, 10532
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Beth Israel Medical Center
New York, New York, United States, 10003
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
MD Anderson Cancer Center
Houston, Texas, United States, 77030-3387
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
United States, Utah
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Austria
Studienambulanz Haematologie - Medizinische Universitaetsklinik
Innsbruck, Austria
Elisabethinen Krankenhaus
Linz, Austria
Onkologische Tagesklinik - Univ. Klinik fur Innere Medizin III - LKH
Salzburg, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria
AKH Wien / MedUni Wien
Wien, Austria
Hanusch Krankenhaus
Wien, Austria
Belgium
Ziekenhuis Netwerk Antwerpen
Antwerpen, Belgium
AZ Sint-Jan Brugge - Oostende AV
Brugge, Belgium
Universite Catholique de Louvain
Brussels, Belgium
Centre Hospitalier De Jolimont-Lobbes
La Louviere, Belgium
Cliniques Universitaires Ucl De Mont-Godinne
Yvoir, Belgium
France
CHU d'Amiens - Hopital Sud
Amiens Cedex, France
Centre Hospitalier De La Cote Basque
Bayonne, France
CHU de Lyon - Hopital Edouard Herriot
Lyon, France
Centre Regional De Lutte Contre Le Cancer - Institut Paoli Calmettes
Marseille, France
CHRU De Montpellier - Hospital St. Eloi
Montpellier, France
Centre Hospitalier De Mulhouse
Mulhouse, France
St Louis/Universite Paris 7
Paris, France
Centre Hospitalier de Perigueux
Perigueux, France
Ch Annecy (Chra)
Pringy Cedex, France
Centre Hospitalier De Saint-Brieuc Yves Ie Foll
St Brieuc, France
CHU de Strasbourg - Hopital Civil
Strasbourg, France
Strasbourg Oncologie Liberale
Strasbourg, France
CHU de Tour - Hospital Bretonneau
Tours, France
Germany
Universitaetsklinik Charite Berlin, Campus Benjamin Franklin
Berlin, Germany
Universitaetsklinikum Carl-Gustav-Carus Dresden
Dresden, Germany
St. Johannes Hospital
Duisburg, Germany
Klinikum Frankfurt Hoechst GmbH
Frankfurt, Germany
Asklepios Klinik Altona
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, Germany
Slk-Kliniken Heilbronn
Heilbronn, Germany
Klinikum St. Georg Ggmbh Leipzig
Leipzig, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
Universitätsklinikum Münster
Munster, Germany
Hungary
University Of Debrecen
Debrecen, Hungary
Petz Aladar Megyei Oktato Korhaz
Gyor, Hungary
Kaposi Mor Oktato Korhaz
Kaposvar, Hungary
Italy
A.O. Ospedali Riuniti Di Bergamo
Bergamo, Italy
Istituto Di Ematologia E Oncologia Medica Seragnoli
Bologna, Italy
Azienda Ospedaliera Spedali Civili Di Brescia
Brescia, Italy
AOU Maggiore della Carità di Novara
Novara, Italy
Poland
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku
Gdansk, Poland
Wojewódzki Szpital Specjalistyczny w Legnicy, Oddzia¿ Hematologiczny
Legnica, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 We Wroclawiu
Wroclaw, Poland
Spain
Hematología clínica ICO Badalona
Badalona, Spain
Hospital Clinic De Barcelona
Barcelona, Spain
Hospital de la Santa Creui Sant pau
Barcelona, Spain
Hospital Universitario De Canarias
La Laguna, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain
Hospital Son Llatzer
Palma de Mallorca, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Clínica Universidad De Navarra
Pamplona/Iruna, Spain
Hospital de Navarra
Pamplona/Iruna, Spain
Hospital Clinico Universitario De Salamanca
Salamanca, Spain
Hospital Virgen Del Rocío
Sevilla, Spain
Hospital Universitario La Fe De Va
Valencia, Spain
Sweden
Sunderby Hospital
Lulea, Sweden
Skånes Universitets sjukhus
Lund, Sweden
United Kingdom
Kings College Hospital and Guys and St Thomas' Hospital
London, United Kingdom
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
Study Chair: Hagop Kantarjian, M.D. M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01303796     History of Changes
Other Study ID Numbers: CYC682-12
Study First Received: February 21, 2011
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cyclacel Pharmaceuticals, Inc.:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Azacitidine
Decitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2015